Notice to stakeholders: Clarifying NPD inactive ingredient policies
April 2024
In advance of a regulatory proposal amending the Food and Drug Regulations to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug (NPD) Action Plan. This Action Plan advances the concepts of the Self-Care Framework to reduce burden where possible and to align the level of oversight of NPDs based on their level of risk. This Action Plan introduces policy and operational- based solutions to remove barriers for getting NPDs (excluding ethical drugs, controlled substances, and biocides) to market.
Through this notice, Health Canada is clarifying the purpose of the Natural Health Products Ingredients Database (NHPID) as it relates to NPDs. For more information about the NHPID, visit the NHPID webpage.
In the evaluation of NPDs, the NHPID serves as an important tool to help industry and Health Canada evaluators in the assessment of ingredients. There are, however, fundamental differences in the way that NHPID content applies to the authorization of NPDs.
The presence of an ingredient and corresponding purpose in the NHPID does not constitute absolute (i.e., guaranteed) approval for use of that ingredient in any health product, including NPDs. The Natural and Non-prescription Health Products Directorate (NNHPD) continues to apply the requirements of the Food and Drugs Act and corresponding Regulations, so as to ensure the accurate representation of drug products. This includes properly listing ingredients as either active or inactive on NPD labelling and supporting product submission documents (e.g., REP-PI form). Sponsors are expected to provide reasonable information with respect to the purpose of ingredients in their products, and in the case of disputes, sponsors have the opportunity to submit additional evidence to support their position within the standard submission screening process.
For additions or modifications to the NHPID, please fill in a Natural Health Products Ingredients Database Issue Form and send to ingredient_support@hc-sc.gc.ca.
Information Resources
Contact Information
Questions can be sent to:
E-Mail: nnhpd-dpsnso@hc-sc.gc.ca
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